Female Viagra-Is This Really A Good Idea?

The FDA has approved the first drug to treat sexual dysfunction in women. Flibanserin also called the “female Viagra” is a drug for premenopausal women who have low sexual desire.

The drug is manufactured by Sprout Pharmaceuticals and the brand name is Addyi. It has been given the go-ahead by the Federal Drug Administration for the treatment of hypoactive sexual desire disorder (HSDD), or low sexual desire.

Up to 40% of women experience HSDD at some time during their lives. 1 in 10 women develop HSDD. Hormonal changes, low-self esteem, stress or fatigue can all contribute to HSDD

While it is not known how flibanserin works, it is believed to correct an imbalance in brain chemicals that handle sexual desire.

The US Food and Drug Administration (FDA) say a 100-mg dose of the drug should be taken once daily just before bedtime. If patients see no improvement within 8 weeks, they should discontinue use of the drug.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” says Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the FDA.

“The FDA strives to protect and advance the health of women,” she continues, “and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

For 24-weeks, 2,400 women with an average age of 36 who had HSDD took either a 100-mg dose of Flibanserin or the placebo before bedtime. The women who took the Flibanserin reported a modest increase in sexual desire and sexual events and a reduction in distress due to low sexual desire.

The most common adverse reactions were nausea, dizziness, sleepiness, fatigue, insomnia and dry mouth. The drug can also cause hypotension-low blood pressure and loss of consciousness, particularly if taken with alcohol. Because of this the FDA has previously rejected the drug twice-once in 2010 and again in 2014.

Due to the risk of potentially serious side effects from the drug, the FDA approval comes with a risk evaluation and mitigation strategy (REMS). This will require all prescribers to complete training on the drug and its side effects before being allowed to prescribe the drug to patients.

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” says Dr. Woodcock. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”

In addition, a Boxed Warning is being applied to flibanserin, informing patients about the risk of hypotension and concussion if taken with alcohol, as well as warning patients with liver impairment or those taking moderate or strong CYP3A4 inhibitors to avoid use of the drug.

The FDA also require that Sprout Pharmaceuticals carry out three well-designed studies to further assess the health risks associated with flibanserin on interaction with alcohol.

The approval comes with mixed reactions from women and health care professionals, because of the risk of potentially serious side effects. Many people are not convinced of its safety or its efficacy. Some have expressed concerns that the FDA has been “pressured by drug companies.” to approve the drug regardless of dangerous side effects.

Some feel that this is a green light for drug companies to manipulate the FDA with their aggressive marketing campaigns.

But despite this criticism, Cindy Whitehead, CEO of Sprout Pharmaceuticals, believes the FDA’s decision to approve flibanserin is the right one:

“It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life-impacting condition.

We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”

The Author

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